新疆地区病毒核酸“11+1”模式集中化检测结果分析

Analysis of Centralized Detection Results of Viral Nucleic Acid through "11+1" Mode in Xinjiang

目的 通过新疆地区核酸集中化检测“11+1”模式,对献血者结果分析及逐年变化趋势进行系统性回顾性探讨分析,探讨集中化检测在效果、检测效率的优势。方法 采用核酸血筛(HBV/HCV/HIV)检测系统,混样(6混或者8混)检测血液核酸HBV DNA、HCV RNA、HIV RNA,混样反应性样本进行拆分单检检测;分析2015年12月-2021年5月期间,委托在乌鲁木齐集中化核酸检测的样本资料、结果的总体分析和地区间差异分析。结果 新疆地区集中化检测的12个地区血液质量在经献血前初筛、酶免检测后,核酸检测结果的血液合格率分别为99.955%(291727/291858)、99.894(1878/1880)、99.963 (8168/8171)、99.938 (1616/1617)、99.916 (19000/19016)、99.783 (2890/2896)、99.813(5856/5867)、99.704(2357/2364)、99.868(15862/15883)、99.822(2238/2242)、99.613(3602/3616)、99.741(1931/1936),“11+1”集中化检测模式共检测357346份样本,其中1家血液中心样本291858,11家血站集中化样本65488,共计68065 pool,拆分325 pool,拆分出212个样本为阳性,其中212份HBV DNA阳性,6份HCV RNA阳性,3份HIV RNA阳性;HBV DNA阳性率分别为0.042%(123/291858)、0.106%(2/1880)、0.037%(3/8171)、0.062%(1/1617)、0.084%(16/19016)、0.207%(6/2896)、0.187%(11/5867)0.296%(7/2364)、0.126%(20/15883)0.178%(4/2242)、0.387%(14/3616)、0.258%(5/1936),两两比较地区间存在差异,核酸检测阳性率有年度下降的趋势。结论 因新疆地大物博很多地州血站每日无偿献血者样本量很少,每月仅开展实验不足10次,“11+1”集中化检测可降低输血传播疾病风险,能够优化检测资源配置,提高输血安全,并且在降低成本、报告及时方面比较有优势,但样本运送途中冷链的控制还需要严格控制。

Objective To explore the advantages of centralized nucleic acid testing in effect and efficiency through the "11+1" model of centralized nucleic acid test in Xinjiang. Methods Nucleic acid blood screening system(HBV/HCV/HIV)was used to detect HBVDNA, HCVRNA and HIVRNA with mixed samples(6 mixed or 8 mixed). The sample data, overall results and regional difference of centralized nucleic acid test in Urumqi from December 2015 to May 2021 were analyzed. Results After preliminary screening and enzyme-free detection, the qualified rate of nucleic acid test results of blood quality in 12 centralized areas in Xinjiang was respectively99.955%(291727/291858), 99.894(1878/1880), 99.963(8168/8171), 99.938(1616/1617), 99.916(19000/19016), 99.783(2890/2896), 99.813(5856/5867), 99.704(2357/2364), 99.868(15862/15883), 99.822(2238/2242), 99.613(3602/3616), 99.741(1931/1936). A total of 357,346 samples through "11+1" centralized detection method were tested including 291858 samples from a blood center, 65488 centralized samples from 11 blood centers. There were a total of 68065 pools. Among them,325 pools were splitted, 212samples were positive, of which 212 samples were HBV DNA positive, 6 samples were HCV RNA positive, and 3 samples were HIV RNA positive. The positive rate of HBV DNA was 0.042%(123/291858), 0.106%(2/1880), 0.037%(3/8171), 0.062%(1/1617), 0.084%(16/19016), 0.207%(6/2896), 0.187%(11/5867)0.296%(7/2364), 0.126%(20/15883)0.178%(4/2242), 0.387%(14/3616), 0.258%(5/1936), there were differences between two comparison regions. The positive rate of nucleic acid test showed an annual decline trend.Conclusion Due to the vast territory and abundant resources in Xinjiang, many prefectural blood stations had few samples of unpaid blood donors every day, and only less than 10 experiments are carried out per month. “11+1”centralized detection can reduce the risk of transfusion-transmitted diseases, optimize the allocation of testing resources, and improve the safety of blood transfusion. There are advantages in cost reduction and timely reporting, but the control of the cold chain during sample shipment still needs to be strictly controlled.